U.S. patent number 5,110,593 [Application Number 07/612,567] was granted by the patent office on 1992-05-05 for irradication and treatment of diaper dermatitis and related skin disorders.
Invention is credited to M. Sue Benford.
United States Patent |
5,110,593 |
Benford |
May 5, 1992 |
Irradication and treatment of diaper dermatitis and related skin
disorders
Abstract
A method and compositions for the irradication and treatment of
diaper dermatitis and related skin disorders whereby the skin is
first cleansed with a non-irritating agent. The cleansed area is
then treated with a specially formulated topical ointment which
contains at a minimum, but is not limited to, a skin conditioning
agent, a barrier agent, and an antimicrobial agent combined with
other vehicles which are chemically capable of ensuring delivery of
the above agents in, at least minimum inhibitory concentration.
Inventors: |
Benford; M. Sue (Dublin,
OH) |
Family
ID: |
24453717 |
Appl.
No.: |
07/612,567 |
Filed: |
November 13, 1990 |
Current U.S.
Class: |
424/401; 424/69;
514/865 |
Current CPC
Class: |
A61K
8/31 (20130101); A61K 8/4926 (20130101); A61K
8/925 (20130101); A61Q 17/00 (20130101); A61K
9/0014 (20130101); Y10S 514/865 (20130101); A61K
2800/75 (20130101); A61Q 17/005 (20130101) |
Current International
Class: |
A61K
8/92 (20060101); A61K 47/00 (20060101); A61K
007/00 () |
Field of
Search: |
;424/401,69,404
;514/941,827,828,865 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Minnich, S. et al., "Effects of Oxyquinoline Ointment on Diaper
Dermatitis" Dermatology Nursing, vol. 3, No. 1, Feb., 1991, pp.
25-28..
|
Primary Examiner: Page; Thurman K.
Assistant Examiner: Colucci; D.
Attorney, Agent or Firm: Kremblas, Jr.; Francis T.
Claims
The embodiments of the invention in which exclusive property or
privilege is claimed are defined as follows:
1. A method of treatment of human skin affected by diaper
dermatitis and related skin disorders by topically applying to said
affected areas an ointment consisting essentially of:
a) about 49 percent by weight of petrolatum;
b) about 15 percent by weight of lanolin;
c) an effective amount of oxyquinoline to provide sufficient
inhibition and inactivation of microbes present in said affected
area to promote healing thereof; and
d) an effective amount of one or more pharmaceutical carrier
vehicles to promote topical application of said ointment without
interfering with the effectiveness of the active agents which
promotes healing of the affected areas, said carrier vehicles being
taken from a group consisting of water, Beeswax, Sodium Borate,
Methyl Salicylate, Sorbitan Sesquioleate, and Trisodium HESTA or
mixtures thereof.
2. The method defined in claim 1 wherein said effective amount of
oxyquinoline is about 0.22 percent by weight.
3. The method defined in claim 1 wherein the application of said
ointment is preceded by cleansing the affected area with an
effective amount of a non-irritating skin cleansing agent.
Description
BACKGROUND
1. Field of Invention
This invention relates to methods and compositions for the
irradication and treatment of diaper rash and related
microbe-compounded diaper dermatitis.
2. Description of Prior Art
Diaper dermatitis, commonly referred to as diaper rash, is a form
of irritation and inflammation that occurs in the area covered by a
diaper. Although it is often dismissed by mothers or physicians as
a minor problem, diaper dermatitis can have serious secondary
sequela. If left untreated, diaper dermatitis can cause masceration
of the skin leading to infections, trauma, and systemic
disease.
"The only children who never have diaper dermatitis are those who
never wear diapers" (Mantel et.al.,1980). This extremely common
skin disorder is not only one of the most prevalent among infants
and young children, but one of the most irritating, painful, and
troublesome conditions facing babies and their mothers.
The precise prevalence of infants who suffer from diaper dermatitis
is unknown. Several studies (Leyden, 1986) estimate that
approximately 10% of infants between the ages of 0 to 2 years will
develop diaper dermatitis although this is considered a gross
underestimation. The peak incidence occurs in the 7 to 9 month age
group. The U.S. Department of Health and Human Services has
indicated that diaper dermatitis itself accounted for 97 visits to
a physician for every 1000 infants in the United States between the
ages of 0 to 2 years of age (DHHS, 1978). As most cases of diaper
dermatitis are treated with over-the-counter (OTC) products, this
statistic most likely reflects only the most severe cases which
required more vigorous treatment.
Other data demonstrate that infants being treated for otitis media
(ear infections) with antibiotics (e.g. Amoxicillin) were found to
be at higher risk for diaper dermatitis compounded by a fungal
infection such as Candida albicans (Honig et.al., 1988). Although
infants who were breastfed had a lower prevalence and severity of
diaper dermatitis (Benjamin, 1987; Berg, 1987), many infants and
young children are not breastfed for long periods of time and/or
are placed on supplemental oral feedings.
It is generally accepted that true diaper rash begins as a contact
irritant dermatitis. The irritation from simple diaper dermatitis
results from constant exposure of weakened or immature skin to
urine or feces or both. The most commonly accepted list of factors
linked to diaper dermatitis include ammonia, bacteria, the
bi-products of bacterial action, urine pH, Candida albicans and
moisture (Berg, 1987). In addition, the use of commercially
available perineal cleansing wipes that contain alcohol and/or
fragrances only serve to further irritate already exposed and
compromised skin tissue.
Attempts to irradicate diaper dermatitis have heretofore been
exclusively directed toward counteracting suspected causes of
dermatitis by utilizing compositions which:
1. Promote dryness; or,
2. Provide barriers in the forms of zinc oxide, petrolatum-based
substances, and lipase-inhibiting agents such as zinc chloride;
or,
3. contain anti-inflammatory steroidal preparations.
Up until the present time, the treatments used for the alleviation
of diaper dermatitis have focused almost exclusively on providing a
barrier against common irritants. The action of these commonly used
preparations is to protect the infant's sensitive skin from
deterioration. Unfortunately, these preparations do little to
nothing to stop the further breakdown of the skin once a full blown
case of diaper dermatitis is evidenced. In fact, many pediatricians
have observed that once a case of diaper dermatitis has begun, the
use of air occlusive (e.g. barrier types) ointments and creams
hinders the healing process (Mantel et.al.,1980).
One example of a popular OTC diaper dermatitis treatment which
employs a barrier method is Desitin.RTM. ointment, a product of
Pfizer, Inc. It contains two of the common barrier substances (zinc
oxide and petrolatum) and additionally contains two common skin
conditioning agents (cod liver oil and lanolin). In a recent study
(to be described in detail later in this document), Desitin.RTM.
ointment was utilized as one of the treatments under study and
found statistically inferior to other products.
Recent research indicates that there is a significant correlation
between the existence of bacteria and yeast in an infant's perineal
area and the presence of diaper dermatitis. The upsurge in
physician use of antibiotics to treat infants with ear infections
has been linked to a new variety of diaper dermatitis that is
compounded by bacteria and yeast (fungus). Thus, the use of
currently available barrier methods in reusable tubes and/or
containers is no longer effective in treating the vast majority of
diaper dermatitis occurrences and could possibly worsen a
dermatitis because they inhibit the healing process and subject the
baby to repeated exposure to a contaminated product. In addition,
the use of barrier method agents that are packaged in reusable
containers makes transport of offending microbes from one infant to
another a likely possibility.
It is apparent from the above discussion that diaper dermatitis can
be a very troublesome ailment for the infant and young child. While
there are over-the-counter products available that purport to be
effective in the treatment of diaper dermatitis, most of these
products are considered ineffective because they
1. are only effective when used in the prevention of diaper
dermatitis, not the treatment;
2. are of little value once the infant's skin has broken down and
diaper dermatitis is evidenced;
3. are ineffective in combating a diaper dermatitis which is
compounded by the presences of bacteria and/or fungus;
4. are frequently dispensed in multi-dose, reusable containers
which render the product subject to contamination and could
potentially worsen an existing case of diaper dermatitis; and,
5. are rarely used in conjunction with an effective cleansing
methodology. In fact, it is extremely difficult to cleanse the
infant's skin once these products have been applied.
OBJECTS AND ADVANTAGES
Accordingly, there are many objects and advantages to the current
methods and compositions of this invention including:
1. to provide a composition which is effective in the treatment of
diaper dermatitis as demonstrated in a relevant clinical study (to
be discussed later in this application);
2. to provide a composition which is effective as, but not limited
solely to, a barrier against common irritants;
3. to provide a composition which is effective as, but not limited
solely to, a skin conditioning agent;
4. to provide a composition which is effective in the treatment of
diaper dermatitis which is complicated by bacteria and or yeast
infections;
5. to provide a method for more effective treatment of diaper
dermatitis which includes proper cleansing with a specific type of
cleansing agent followed by the application of an effective
composition; and,
6. to provide a method for dispensing said compound in such a
manner as to eliminate the potential for product contamination.
PERTINENT DEFINITIONS PERTAINING TO THE INVENTION
The following terms are germane to the understanding of this patent
application and will be defined in the following discussion.
By the term "affected area", as used herein, is meant the area of
human skin which is presently exhibiting any of the described
levels of diaper dermatitis or related skin disorder. The term will
also include the area immediately proximate to the described area.
The term describes the area in which treatment and irradication is
desired.
By the term "single-dose application", used herein is meant a
container or other such holding mechanism that contains the amount
of composition required for only one topical application of a
diaper dermatitis composition to be applied to the affected area at
a given time. Said container is immediately disposed of following
the application.
By the term "safe and effective microbial agent", as used herein is
meant a chemical agent which will provide inhibition or
inactivation of microorganisms necessary for the successful
treatment of diaper dermatitis compounded by the presence of
bacteria or fungus. Additionally, the agent must demonstrate a
reasonable benefit/risk ratio attended with any accepted
therapeutic treatment.
By the term "antimicrobial agent", as used herein is meant that the
compound modified by this term demonstrates the ability to reduce,
inhibit, or stop the growth and/or activity of microorganisms known
to compound diaper dermatitis and related skin disorders.
By the term "effective amount of non-irritating skin cleansing
agent", as used herein is meant an amount of cleansing agent which
will aid in removing body waste and other irritants without itself
causing undue irritation.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a rating scale used to assess diaper dermatitis;
FIG 2 is the proportion of infants showing an improvement.
DESCRIPTION OF THE INVENTION
The methods and compositions of the present invention relate to the
treatment and irradication of diaper dermatitis and related skin
disorders caused by prolonged exposure to skin tissue irritants
with potential bacterial and fungal complications. The methods and
compositions of this invention require, at a minimum, but are not
limited to the following:
1. as the initial step in the method, an effective amount of
non-irritating skin cleansing agent applied to the affected area
with either a disposable or reusable wipe, cloth, or other such
vehicle; followed by:
2. a safe and effective amount of pharmaceutically-acceptable
antimicrobial agent such as, but not limited to oxyquinoline,
which, when topically applied, is effective in inhibiting the
growth of microbes found to compound simple irritant dermatitis;
and
3. a barrier-type pharmaceutically-acceptable agent such as, but
not limited to petrolatum, which is capable of protecting the skin
against irritants; and,
4. a skin-conditioning pharmaceutically-acceptable agent, such as,
but not limited to lanolin, which is capable of providing
appropriate nourishment for the skin; and,
5. said agents described above in #2, 3, and 4, are combined with a
chemical vehicle which is capable of delivering said agents to the
applied area of at least said agents' minimum inhibitory
concentration; and,
6. the delivery of the above described composition to the affected
area from a single unit-dose application that is disposed of
following administration of said treatment.
The composition of this invention is not limited to the above
agents and may additionally employ other optional
pharmaceutically-accepted components which reduce skin irritation,
act as lipase-inhibiting agents, act as anti-inflammatory agents,
or improve the cosmetic acceptability of the formulation.
COMPONENTS OF INVENTION: NON-IRRITATING CLEANSING AGENT
The diapered areas of an infant or young child is constantly
exposed to a variety of irritants ranging from trapped moisture,
heat, and even potentially-harmful chemical substances. Diaper
dermatitis that develops from exposure to these irritants is a
troublesome, distressing problem. Left unattended, a dermatitis can
quickly spread throughout the diapered area as it progresses from
macules and papules to eroded, or crusted lesions (Scipien,
1974).
Infants are especially prone to irritant exposure and subsequent
infection due to their highly permeable epidermis which results
from an immature stratum corneum. Chemical and physical insults,
such as ammonia, alcohol, commercially-used fragrance, and
friction, decrease the ability of the epidermis to maintain the
integrity of the stratum corneum resulting in the development of
cutaneous lesions and potentially severe skin breakdown.
The methods of this invention include as the initial step, the use
of an effective amount of non-irritating skin cleansing agent for
the gentle cleansing of the diapered area of the infant prior to
the topical application of the single-dose composition heretofore
mentioned. No other diaper dermatitis remedy or treatment protocol
specifies that cleansing is an essential component of the treatment
of the disorder and includes this in combination with the secondary
intervention of a single-dose antimicrobial topical
application.
COMPONENTS OF INVENTION; CHEMICAL FORMULATION
An integral component of the composition of this invention is the
application of a topical ointment which contains, but is not
limited to the following ingredients:
______________________________________ Petrolatum 49.00% Lanolin
15.50% Water Beeswax Sodium Borate Lanolin Alcohols Methyl
Salicylate Sorbitan Sesquioleate Methylparaben Oxyquinoline 0.22%
Propylparaben Trisodium HESTA
______________________________________
At this time, the composition is currently referred to as Bottom
Better.TM. and will soon be available for commercial distribution.
However, dispensing of the above described formulation may not be
limited to the aforementioned product name.
It is important to note that the above mentioned chemical agents,
when combined in the above mentioned quantities (but not limited to
this formulation), is in compliance with the most recent Food and
Drug Administration (FDA) guidelines for OTC diaper dermatitis skin
care treatments (Dept. of Health & Human Services, June 1990).
Additionally, there are currently NO over-the-counter diaper rash
treatments which employ the aforementioned combination of
ingredients in the quantities listed. The antimicrobial agents of
said composition of the present invention are used at levels which
are both safe and effective when topically applied to the affected
area.
The composition of this invention can be applied from one to twelve
times per day, either at diaper changes or incontinence pad changes
and wound cleansings. The application rate will vary with the
severity of the condition, the average length of exposure to
irritants, and common practice procedures recommended by health
care practitioners.
COMPONENTS OF INVENTION; ANTIMICROBIAL AGENT
Oxyquinoline, also known as 8-hydroxyquinoline, is a white or
faintly yellow crystalline powder with a pleasant characteristic
odor. Its chemical formula is C.sub.9 H.sub.7 NO. One gram of
oxyquinoline dissolves in 1500 ml of water. It is freely soluble in
alcohol, acetone, chloroform, benzene, and mineral acids
Oxyquinoline is obtained by heating 0-aminophenol with
O-nitrophenol, glycerol, and sulfuric acid. It has bacteriostatic,
fungistatic, deodorant, and keratolytic properties. The
oxyquinolines are contained in currently marketed products in
concentrations of 0.06 to 2.5%.
Oxyquinoline has been known for its antimicrobial and antifungal
qualities for decades. The drug itself has been on the market in
the United States and Europe since 1906 and is widely used in
several skin-related treatment protocols (Rohde et.al., 1986).
COMPONENTS OF INVENTION: SINGLE-DOSE APPLICATORS
In the methods of the present invention, any stability-tested and
approved container, packette, applicator, or other such holding
device may be employed to deliver a single dose of the
aforementioned composition. The amount contained within the
single-dose application may vary with the type of skin disorder,
size of the affected area, and/or intensity of the condition. A
suggested range might be approximately 0.2-0.5 ounces of substance
per single dose application. Instructions for use of the
composition would include that the user should dispose of the
holding device immediately following dispensing of the composition
to the affected area.
CLINICAL TESTING OF THE INVENTION
In order to test the safety and efficacy of this invention, a
clinical study was conducted to compare the treatment protocol
described in the invention with existing over-the-counter diaper
dermatitis treatments (NOTE: two top market products were selected
for the comparison study). Both of these products are only
available in multi-use, reusable containers.
METHODOLOGY
A randomized double-blind trial was designed by the Biometrics
Laboratory in the College of Medicine at the Ohio State University.
Procedures for subject selection, randomization, data collection
and rating of the rash were formalized in accordance with commonly
accepted design principles. Sample size was calculated based on the
ability to detect a large difference in the proportions showing
improvement between groups. When the proportion of infants in the
control group who showed improvement was 10%, then a sample size of
17 per group was needed to detect a 70% proportion showing
improvement in the experimental treatment with a power of 95% and
setting alpha at 0.05 (Fleiss, 1981).
Participants were solicited from licensed day-care facilities and
from private homes in Columbus, Ohio from Jul. through Oct. 1989.
Six large licensed facilities agreed to participate and signed
parental consent was obtained prior to study participation.
At the beginning of each study day, in the centers and in the
homes, the diapered area was examined by the research assistant. A
five level grading scale was used to assess rash presence and
severity (see FIG. 1). The diaper dermatitis grades reported are
based on the perceptions of the degree of severity and extent of
the rash as recorded by a trained observer. Grades of B or less
(skin slightly pink to no rash evident) were not generally regarded
as being diaper rash by the mothers. A minimum beginning rash level
of grade C (skin pink with pimply areas) was considered necessary
for inclusion in the study.
The study utilized a double-blind research design. The principal
investigator randomized eligible infants into control versus
treatment groups while the blinded research assistant determined
rash levels. Information was gathered for all participants
concerning preexisting skin disorders, use of medication, recent
presence of diarrhea for 24 hours or more, birth date, race,
gender, allergies, other health problems and type of diaper used.
Infants with preexisting skin disorders or with active diarrhea
were excluded from the study in order to control for possible
confounding variables.
Each eligible child was randomized into either the control or
experimental group. All caregivers were instructed by the principal
investigator, a registered nurse, in proper technique for using and
applying the selected substance. Caregivers for those in the
experimental group were instructed in the use of an effective
amount of non-irritating skin cleansing agent followed by the
application process for the experimental substance. Caregivers for
those in the control group were instructed to clean the diapered
area using the current method and vehicles followed by the
application process for the control substance (instructions for
control substances were taken from manufacturer printed
instructions on the product). A one ounce container of oxyquinoline
containing ointment was provided for usage during the six hour time
period (NOTE: since the time period for the study intervention was
not long enough for growth of microbial agents in the experimental
treatment container, a two to three application reusable container
was employed for the study).
In all cases, the controls used either Desitin.RTM. or A&D
Ointment.RTM. as the study treatment. In both groups, the principal
investigator stressed the importance of keeping the research
assistant blinded by instructing the caregiver to wash off the
treatment and remove the diaper prior to the return visit of the
research assistant for final grading.
Rashes were graded prior to treatment according to severity using a
five level scale shown in FIG. 1. A post treatment measure of
severity was obtained by the same observer after an interval of
between five and nine hours. A change in rash severity was
considered to have occurred only if a one grade or more difference
was observed.
RESULTS
The results of this study overwhelmingly supported the
effectiveness claims. A total of 34 infants were eligible for
study, 17 were randomized into the experimental group and I7 into
the control treatment group. The mean age was I2.5 months with 19
of the infants being male and 15 female. The majority of infants
were white, although one subject in the experimental group was
biracial. Only two study participants, one in each of the groups,
was using antibiotics and only three of the 34 subjects (two in the
control group and one in the experimental) used cloth diapers. No
children in the study were being breastfed at the time of study.
Five brands of disposable diapers were encountered during the study
and no one brand was predominant in any group after
randomization.
Characteristics of the study population are presented in Table 1. A
comparison for possible differences between the experimental and
control group with respect to gender (p=1.00), beginning rash level
(p=0.92), and site of study being in-home or day-care (p=1.00) was
performed. Chi-square or Fisher's exact test for dichotomous
variables) revealed no statistically significant differences
between groups (Fleiss, 1981). Independent sample t-tests were used
to compare mean age and time interval between initial and final
observation between treatment groups. No differences were found
between groups for age (p=0.13) and observation time interval
(p=0.64). Thus, the treatment groups were found to be similar with
respect to basic characteristics.
Overall, two of the 17 control subjects improved at least one grade
level while 13 of the 17 experimental subjects made at least the
same degree of improvement. In the control group, two participants
had rashes which worsened one grade. In the experimental group one
child had a two grade improvement and no children worsened.
Due to the small sample sizes, Fisher's exact test was used to
compare the unadjusted proportions of infants who showed
improvement. There was a dramatic difference with a larger number
of children showing improvement in the experimental group, see FIG.
2.
TABLE 1 ______________________________________ Characteristics of
the Study Population Children with Diaper Dermatitis Control
Treatment (Desitin or A & D) (Oxyquinoline) Total
______________________________________ Gender Male 9 10 19 Female 8
7 15 Mean Age in 14.1 10.9 12.5 Months (s.d.)* (6.8) (5.1) (6.2)
Beginning Rash Level C 5 5 10 D 7 6 13 E 5 6 11 Study Site Home 9 9
18 Day-care 8 8 16 Mean Time 6.2 6.0 6.1 from initial to final
observation (in hours) (s.d.)* (0.8) (1.0) (0.9)
______________________________________ *Standard Deviation
Ninety-five percent confidence intervals for the proportions were
calculated for each of the treatments using the exact binomial
distributions (Hollander & Wolfe, 1973). As presented in Table
2, the majority of the experimental group showed improvement
(76.5%, 95% C.I.=50.1-93.2) whereas only 11.8% of the control group
improved (95% C.I.=0.7-36.5) Individual group values are presented
in Table 2. The proportion showing improvement in the experimental
group versus the combined control group was significantly different
(p<0.001).
A further comparison of the treatments for improvement was done by
adjusting separately for possible confounding variables such as
gender, beginning rash levels, place of study, age and observation
time interval. Mantel-Haenszel chi-square test statistics (Pocock,
1983) were used to adjust the relative rates of improvement
(ratios) for possible differences in the above confounders. This
approach is valid for our sample sizes according to the criteria
recommended by Mantel and Fleiss (Mantel & Fleiss, 1980). When
adjusting for any of these variables, the experimental group still
showed significantly higher improvement rates. The unadjusted
relative risk was 6.5 (95% C.I.=2.4-17.3) for the probability of
improvement for the experimental group relative to the control
group. The adjusted ratios were similar to the unadjusted as seen
in Table 3.
A further consideration was whether differences existed between the
control treatments of Desitin.RTM. and A & D Ointment.
Desitin.RTM. users (n=9) and A & D users (n=8) were compared
separately to the experimental treatment.
TABLE 2
__________________________________________________________________________
Comparison of Percentage Improvement of Diaper Dermatitis for the
Oxyquinoline Treatment Group versus the A & D Ointment Group.
Desitin Ointment Group and the Combined Control group of Desitin
and A & D Ointment Users. Number Tested Number Improved Percent
Improved P-Value*
__________________________________________________________________________
Oxyquinoline 17 13 76.5 Combined Control 17 2 11.8 <.001 Desitin
9 1 11.1 .007 A & D 8 1 12.5 .007
__________________________________________________________________________
*Using Fisher's Exact Test to Compare each Control Treatment with
Oxyquinoline
TABLE 3 ______________________________________ Ratio of the
Probability of Improvement for the Oxyquinoline Group Relative to
the Combined Control Treatment Group. Adjusted for Other Variables.
Adjustment Ratio of Improvement, Adjusted Variable (95% Confidence
Interval) ______________________________________ Gender 6.6 (2.5,
17.6) Beginning 6.7 (2.4, 18.7) Rash Level Care Location 6.5 (2.4,
17.5) Home or Day-Care Infant Age* 7.9 (2.9, 21.6) Observation 7.1
(2.5, 20.3) Time Interval** Unadjusted 6.5 (2.4, 17.3) Ratio
______________________________________ *Age was dichotomized into
younger infants (less than 12 months) and olde infants (12 months
or older). **Observation Time Interval was dichotomized into short
(less than 6 hours) and long (6 hours or more).
No analysis was made comparing Desitin.RTM. and A & D. No
differences were seen for the experimental group versus
Desitin.RTM. or versus A & D users with respect to age, gender,
beginning rash level, place of study and observation time interval.
Percent showing improvement was also similar between the products
with an 11.1% rate for Desitin.RTM. and a 12.5% rate for A & D,
values are shown in Table 2. The proportion showing improvement in
the experimental group versus the Desitin group (p=0.003) and
versus the A & D Ointment group (p=0.007) were shown to be
different using Fisher's exact test. Stratified analysis was not
possible due to the small sample sizes involved when considering
brand-specific control treatments.
DISCUSSION
The experimental treatment consisting of an effective amount of
non-irritating skin cleansing agent followed by the single dose
application of a ointment containing oxyquinoline 0.22% was shown
to have significantly greater proportions of infants demonstrating
improvement in diaper rash than the control treatments of
Desitin.RTM. and A & D Ointments in a double-blind randomized
clinical trial.
No side effects or worsening of the rash was seen in any of the
experimental infants whereas two infants did experience a worsening
rash using Desitin.RTM.. Of the four infants in the experimental
group who were not rated as showing any improvement, one in fact
did improve. The particular infant had a beginning rash level of E
and was considered to have the most severe rash encountered by the
study group. Although the child did show marked improvement over
the observation interval, it was not sufficient to be considered in
a less severe rash category and was classified as a
non-improvement.
Caregivers were frequently unaware of the importance of cleansing
the diaper area as part of the diaper changing process,
particularly when the diaper was merely `wet` with urine. The fact
that alcohol and fragrance containing wipes may further irritate
infant skin was also not widely known. In addition, most of the
popular over-the-counter diaper rash treatments do not contain
sufficient antibacterial or antifungal agents and thus are not
always effective once diaper dermatitis is present. Caregivers were
not aware that these products are best used as preventive measures
against diaper dermatitis rather than active therapy for a
rash.
Despite vigilant preventive measures such as cleansing the diaper
area with an effective amount of non-irritating skin cleansing
agent, frequent changes and ointment use, diaper dermatitis may
occur. It was therefore encouraging to find that, despite the small
sample size, results of the trial demonstrate that the invention
methodology of using an effective amount of non-irritating skin
cleansing agent followed by the application of said invention in a
single dose application form was superior in improving diaper
dermatitis.
SUMMARY OF THE INVENTION
Diaper dermatitis is a major problem potentially affecting, but not
limited to, any infant or young child who wears diapers. Most
health care professionals concur that diaper dermatitis is a
problem which, if left untreated, can have serious secondary
sequelae. Additionally, the incidence of diaper dermatitis is
grossly underreported. What is needed is a readily-available (e.g.
over-the-counter) treatment methodology which is both safe and
effective.
A review of the prior art in this area reveals that although other
over-the-counter treatments are available, they:
1. are only most effective when used in the prevention of diaper
dermatitis, not the treatment; and,
2. are of little value once the infant's skin has broken down and
diaper dermatitis is evidenced; and,
3. are ineffective in combating a diaper dermatitis which is
compounded by the presences of bacteria and/or fungus; and,
4. are frequently dispensed in multi-dose, reusable containers
which render the product subject to contamination and could
potentially worsen an existing case of diaper dermatitis; and,
5. are rarely used in conjunction with an effective cleansing
methodology. In fact, it is extremely difficult to cleanse the
infant's skin once these products have been applied.
The present invention encompasses methods and compositions for the
topical treatment and irradication of diaper dermatitis and other
skin-related diseases associated with (but not limited to)
prolonged exposure to urine, feces, bacteria, or fungus. The
methods and compositions act to provide effective treatment and
irradication of diaper dermatitis by effectively cleansing the
affected area in the aforementioned manner thereby preventing the
action of the irritants against an infant's tender skin.
Following effective cleansing, a topical ointment, described in the
preceding sections, is applied. The topical ointment uniquely
combines chemical agents which are found to be most effective in
the treatment of diaper dermatitis.
The unique approach described in the compositions and methods of
this patent application offers many objects and
advantages--especially compared to what is currently available on
the market. Primarily, the objects and advantages include:
1. to provide a composition which is effective in the treatment of
diaper dermatitis as demonstrated in a relevant clinical study;
2. to provide a composition which is effective as, but not limited
solely to, a barrier against common irritants;
3. to provide a composition which is effective as, but not limited
solely to, a skin conditioning agent;
4. to provide a composition which is effective in the treatment of
diaper dermatitis which is complicated by bacteria and/or yeast
infections;
5. to provide a method for more effective treatment of diaper
dermatitis which includes proper cleansing with a specific type of
cleansing agent followed by the application of an effective
composition; and,
6. to provide a method for dispensing said compound in such a
manner as to eliminate the potential for product contamination.
Although the description above contains many specificities, these
should not be construed as limiting the scope of the invention, but
as merely providing examples of some of the potential uses of this
invention. For example, the methods/compositions of this invention
could be used on other persons who may have to wear diapers such as
an incontinent patient or a bed-ridden patient.
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